Arch Plast Surg.  2020 May;47(3):235-241. 10.5999/aps.2019.01858.

BellaGel breast implant: 6-Year results of a prospective cohort study

• Oh JS
• Jeong JH
• Myung Y
• Oh J
• Kang SH
• Park E
• Kim A
• Bang SI
• Heo CY

• KMID: 2501170
• DOI: http://doi.org/10.5999/aps.2019.01858

Abstract

Background
This is the first clinical study conducted among Asian women using breast implants manufactured by an Asian company. Four-year data regarding the safety and efficacy of BellaGel breast implants have already been published, and we now report 6-year data.
Methods
This study was designed to take place over 10 years. It included 103 patients who underwent breast reconstruction or augmentation using BellaGel breast implants. The rates of implant rupture and capsular contracture were measured and analyzed to evaluate the effectiveness of the breast implant.
Results
At patients’ 6-year postoperative visits, the implant rupture and capsular contracture rates were 1.15% and 2.30%, respectively. The implant rupture rate was 3.77% among reconstruction cases and 0% among augmentation cases. The capsular contracture rate was 5.66% among reconstruction cases and 0.83% among augmentation cases.
Conclusions
The 6-year data from this planned 10-year study suggest that the BellaGel cohesive silicone gel-filled breast implant is an effective and safe medical device that can be used in breast reconstruction and augmentation.

Keyword

Breast implant; Mammaplasty; Capsular contracture